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Completed

NCT Number: NCT07542275

Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Graftless Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study.

This present study will evaluate Schneiderian membrane perforation rates using osseodensification in TSFE with simultaneous graftless implant placement, under sinuscopic control monitored by an ENT specialist.

An endoscopic evaluation will be continuously conducted throughout the surgical procedure. TSFE will be performed using Densah burs without the addition of bone graft material, followed by implant placement. The rationale behind this approach is to monitor the response of the Schneiderian membrane and assess the effects of Densah burs on membrane distention and the occurrence of SMP.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Joseph University of Beirut

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males and females over 21 years of age;
  • partial edentulism in the posterior maxilla involving 2 or more adjacent teeth in the premolar-molar area;
  • teeth at the intended implant sites must have been extracted or lost at least 9 months before the date of implant surgery;
  • sinus floor with a relatively flat contour confirmed on baseline CBCT;
  • bucco-palatal sinus width (distance between the buccal and palatal walls at 10-mm apical level comprising the residual alveolar crest ) 8-12 mm confirmed on baseline CBCT to minimize the risk of SMP during surgery (Stacchi et al. 2022);
  • sinus membrane thickness ≤ 2 mm;
  • subsinus residual bone height (RBH) 4-6 mm at the intended implant sites and bucco-palatal bone width allowing implant placement without bone augmentation procedures.

Exclusion criteria

  • systemic conditions contraindicating implant surgery;
  • pregnancy or lactation;
  • ongoing or history of pathologies or medications affecting bone metabolism;
  • ongoing or history of head and neck irradiation;
  • oral inflammatory and autoimmune diseases;
  • presence of osseous lesions or persistent infections in the planned implant sites;
  • previous bone augmentation surgery;
  • uncontrolled periodontal diseases;
  • heavy smoking (> 10 cigarettes/day);
  • history of sinus surgery;
  • presence of intrasinus bony septa that could affect membrane elevation and distention; and
  • ongoing or history of rhinitis or sinusitis.

Treatment and study plan

Scheiderian Membrane Perforation

Device

Assess endoscopically any Scheiderian membrane perforation while performing transcrestal sinus floor elevation using the densah burs

Primary outcomes

  1. incidence of Scheiderian membrane perforation

    Time frame: Perioperative

    The primary aim of the present clinical study is to evaluate the incidence of SMP during TSFE with immediate implant placement performed by a trainee surgeon using the osseodensification technique under sinuscopic control in sinuses of comparable contour

Secondary outcomes

  1. primary stability achieved by the implants at insertion measured with the insertion torque value, in N.cm

    Time frame: Perioperative

    studied in all cases

  2. qualitative pattern of membrane distention, differentiated into either a U-shaped dome or a V-shaped dome

    Time frame: Perioperative

    Studies in case of SMP occurrence

  3. time at which the potential perforation occur

    Time frame: Perioperative

    Studies in case of SMP occurrence

  4. Size of potential perforations, in mm, classified as pinhole <1mm, small >1mm and <2mm, medium >2mm and < 3mm, large >3mm

    Time frame: Perioperative

    Studied in case of SMP occurrence

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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